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Home > Protocol Summaries: Compounds > eltrombopag > Protocol Summary for TRA110087

Protocol Summary for TRA110087

Protocol Summary
Protocol Id: TRA110087
Secondary Ids:
Title: Eltrombopag Pediatric Formulation Taste Testing in Healthy Adult Volunteers
Phase: Phase 1
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: yes
IND/IDE Grantor: CDER
IND/IDE Number: 63293
IND/IDE Serial Number: 0154
Has Expanded Access?:
Study Type: interventional
Oversight Authority:
  • United States : Food and Drug Administration
Collaborators:
Brief Summary: Based on a need for a pediatric formulation of eltrombopag for the treatment of pediatric thrombocytopenia, this study will help determine the best tasting pediatric formulation of eltrombopag. Healthy adult volunteers who are able to taste bitterness and who do not have a high sensitivity to bitterness will be enrolled. The subjects will evaluate different formulations and rate them based on the bitterness and effectiveness of sweetners. The outcome of this study will help support a decision for a new pediatric formulation of eltrombopag.
Detailed Description:
Record Verification Date: September 2009
Status: Completed
Why Study Stopped:
Study Start Date: May 2007
Study Completion Date:
Study Completion Date Type:
Primary Completion Date:
Primary Completion Date Type:
Primary Purpose: Treatment
Allocation: Randomized
Masking: Single Blind
Masked Subject:
Masked Caregiver:
Masked Investigator:
Masked Assessor:
Study Design (Assignment): Single Group Assignment
Study Classification (Endpoint): None
Primary Outcomes:
  • To establish a taste preference of eltrombopag in a pediatric formulation taken at initial dosing, 3hours, and 6 hours on Day 1 & 2. at initial dosing, 3hours, and 6 hours on Day 1 & 2.
Secondary Outcomes:
  • - physical exam and an echocardiogram (ECG) will be done at Day 1 & 2 done at Day 1 & 2
  • Saftey will be monitored by: - vital signs and clinical labs will be taken at all visits all visits
Conditions:
  • Purpura, Thrombocytopaenic, Idiopathic
Keywords:
  • healthy adult volunteers
  • eltrombopag
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Years
Maximum Age: 55 Years
Enrollment: 12
Enrollment Type: Actual
Healthy Volunteers?: yes
Central Contact: US GSK Clinical Trials Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact: EU GSK Clinical Trials Call Center
Backup Central Contact Phone: +44 (0) 20 8990 4466
Backup Central Contact Email: GSKClinicalSupportHD@gsk.com
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: Click to view location information